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Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03788174
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Brief Summary:
In previous studies,the investigators found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now the investigators are going to start a phase 2 trial with apatinib 500mg + POF as second-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: Apatinib Drug: POF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study on the Second-line Treatment of Gastric Adenocarcinoma With Apatinib Combined With POF(Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Apatinib plus POF
Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
Drug: Apatinib
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.

Drug: POF
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.




Primary Outcome Measures :
  1. Objective response rate [ Time Frame: From enrollment to 3 months after treatment ]
    According to RECIST 1.1


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From enrollment to progression of disease. Estimated about 12 months. ]
    The length of time from enrollment until the time of progression of disease

  2. Overall survival [ Time Frame: From enrollment to death of patients. Estimated about 18 months ]
    The length of time from enrollment until the time of death

  3. Toxicity According to NCI CTCAE 4.03 criteria [ Time Frame: From enrollment to 3 months after treatment ]
    According to NCI CTCAE 4.03 criteria



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
  • Previous first-treatment with chemotherapy or radiation therapy failed. Ability to take medications orally. With measurable lesions. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
  • Life expectancy ≥3 months. With normal electrocardiogram results and no history of congestive heart failure.
  • Without bleeding and thrombosis disease. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion Criteria:

  • Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
  • Patients with brain or central nervous system metastases, including leptomeningeal disease.
  • Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound, ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
  • History of a stroke or CVA within 6 months. Clinically significant peripheral vascular disease. Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788174


Locations
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China, Fujian
Rongbo Lin Recruiting
Fuzhou, Fujian, China, 350014
Contact: Rongbo Lin, MD    86+13705919382    rongbo_lin@163.com   
China
Rongbo Lin Recruiting
Fuzhou, China, 350014
Contact: Rongbo Lin    13705919382 ext 13705919382    rongbo_lin@163.com   
Sponsors and Collaborators
Fujian Cancer Hospital

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03788174     History of Changes
Other Study ID Numbers: FNF013
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorouracil
Apatinib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors